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CE Mark

Meaning

The CE Mark is a mandatory conformity marking for products placed on the market within the European Economic Area (EEA), signifying that a product meets the essential health, safety, and environmental protection requirements set out in relevant European directives. For medical devices, including many diagnostic tools and therapeutic technologies used in hormonal health, this mark is a critical regulatory passport. It is a declaration by the manufacturer that the product complies with all applicable EU regulations, allowing for free movement within the European single market. The mark provides assurance of regulatory adherence, not necessarily clinical efficacy.